Wuhan Calmland Pharmaceuticals Co., Ltd. founded in January 2014 and located in Wuhan East Lake High‑Tech Development Zone, is a modern pharmaceutical enterprise focusing on the R&D and manufacturing of oncology products, high‑end high‑value‑added active pharmaceutical ingredients (APIs) and pharmaceutical intermediates.Boasting a mature and compliant manufacturing system, the plant was officially commissioned in September 2014. It has successfully passed GMP audits by China NMPA, US FDA and EU EDQM, with all operations conducted in alignment with international pharmaceutical standards.

The company’s products feature strong competitiveness in the global market supported by a comprehensive qualification portfolio: 7 products have completed US FDA DMF filings, 5 have obtained EU CEP certificates, and 8 hold CDE registration numbers in China (6 of which have been converted to Status A). Product quality complies with major global pharmacopoeia specifications, fully meeting procurement and market access requirements of high‑end customers at home and abroad.

The manufacturing site is designed and constructed in strict accordance with GMP, cGMP and EU GMP international standards. Separate workshops are arranged for cytotoxic oncology products and non‑cytotoxic products with a scientific and standardized production layout. A standardized secondary reverse osmosis plus EDI purified water system is installed as supporting utility, with water quality meeting the requirements of USP, EP and ChP, so as to guarantee the purity and safety of pharmaceuticals from the source.

The company operates a fully‑equipped professional analytical testing center capable of independent end‑to‑end quality testing including chemical analysis, instrumental analysis, sterility and microbiological testing, and stability studies. The center is equipped with high‑end international precision instruments from Agilent, Waters, PerkinElmer and other suppliers, delivering accurate and compliant testing results for comprehensive quality control.

A closed‑loop standardized management system covering materials, production, quality, equipment, sanitation and registration has been established within the company. International GMP requirements are strictly followed throughout operations to achieve full traceability of the manufacturing process and controllability of quality risks. Centered on high quality standards, the company keeps supplying safe, consistent and high‑quality biopharmaceutical raw materials for customers worldwide.